The goal of this project is to develop an effective treatment for locoregional control of metastatic pancreatic cancer and, more generally, peritoneal tumors, which affect 230,000 new patients annually in the United States. For patients with carcinomatosis, there are no therapeutic options and only palliative treatments (e.g., costly procedures such as repeated drainage of peritoneal fluid). Optimum has developed tumor-penetrating microparticles (TPMs), a first-in-class delivery system tailored to the unique anatomical properties of the peritoneal cavity. TPMs are multicomponent, multifunctional, biocompatible, biodegradable, controlled-release polymeric micron-size particles. TPMs are designed to target, penetrate and deliver pharmacodynamically optimized drug levels to the superficial and deep layers of peritoneal tumors. TPMs represent a delivery platform that can be used to deliver small molecule therapeutics, biologics, gene vectors and imaging agents. The first generation TPM, TPM001, is loaded with paclitaxel. The lab has made progress towards the completion of the following studies on TPM001: - Manufacture of Good Manufacturing Practice (GMP) drug product - Formulation development - Pharmacokinetic/absorption, distribution, metabolism, and excretion (PK/ADME) studies - Investigational New Drug (IND)-directed toxicology